An FDA advisory committee voted unanimously on Friday to support approving Moderna's seasonal mRNA flu vaccine, ending a review process that had faced an early attempt at a block from a Trump appointee at the agency.
According to Ars Technica, the nine-member committee, known as VRBPAC, the Vaccines and Related Biological Products Advisory Committee, spent a full day reviewing data and presentations on the vaccine before casting a 9 to 0 vote in favor of approval. The vaccine is formally called mRNA-1010 and is branded as mFlusiva.
The data behind the vote came from a Phase 3 trial involving more than 40,000 adults age 50 and older. That trial found the mRNA vaccine was around 27 percent more effective against seasonal flu than a standard flu shot. A separate Phase 3 trial involving nearly 3,000 people age 65 and older showed the vaccine produced stronger immune responses than a high-dose flu shot, which is the currently recommended option for that age group. The safety profile of the vaccine was described as generally good.
Flor Munoz-Rivas, a VRBPAC voting member and pediatric infectious disease expert at Baylor College of Medicine, spoke after the vote. "I think that the studies that were presented today were very well conducted," she said. "They have very clear results that are very robust in terms of demonstrating that additional efficacy."
Munoz-Rivas also pointed to a broader benefit of the mRNA platform itself. The same platform Moderna used to build its COVID-19 vaccines underlies mFlusiva. That design allows for "rapid development of the vaccines in regular seasonal flu activity" and makes us "better prepared for emerging strains or pandemic strains in the future," she said.
The FDA's own scientists submitted a review that was supportive of the vaccine, and that review was presented as part of the all-day meeting. The advisory committee's vote is not a final approval but carries significant weight in the FDA's decision-making process.
